Quality Control Laboratory Compliance -cGMPs and GLPs

One and a Half-day In-person Seminar:

By: Robert C Fish, Consultant, EAS Consulting Group, LLC

SPEAKERRobert C Fish, Consultant, EAS Consulting Group, LLC

LEARNING OBJECTIVES

The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).

Laboratory organization, personnel qualification and training requirements.

Documentation and record-keeping requirements, including e-records and data integrity.

Key goals of the conference will include learning:

Sample integrity requirements.

Management and control of stability (shelf-life) studies

Analytical methods verification and validation.

Management and control of laboratory instruments.

Management and control of laboratory supplies.

Proper conduct of laboratory investigations.

Consequences of laboratory non-compliance.

Location: March 29-30, 2018 | San Francisco, CA

Mr. Fish has been providing independent consulting services since 2003, joining EAS Consulting Group, LLC in November 2006. Prior to that he started work for AAC Consulting Group, Inc. (AAC) in April 1995 after serving 33 years with Food and Drug Administration (FDA). The last 6 years of that service he held the position of Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections' operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office for 8 years and was also a Supervisory Investigator at the Nashville District Office for 8 years. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, dietary supplements, tobacco, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor.

FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions.

In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).

COURSE DESCRIPTION

WHO WILL BENEFIT

Quality Assurance

Quality Control

Research & Development

Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratoryoperations and practices comply with current good manufacturing practices and good laboratory practices.

02QUALITY CONTROL LABORATORY COMPLIANCE - cGMPS AND GLPSOne and a Half-day In-person Seminar:

AGENDADAY ONE (8.30AM – 4.30PM) DAY TWO: (8.30AM – 1.00PM)

Basics of FDA law and regulations for QC laboratoriesI.

Registration Process: 8:30 AM - 9:00 AMSession Start Time: 9:00 AM

Laboratory OrganizationII.

What is adulteration? Pharmaceuticals Biologics Medical Devices Foods Cosmetics

What is CGMP? Pharmaceuticals Biologics Medical Devices Foods Cosmetics

What is GLP?What is AIP?Contract LaboratoriesFDA inspection methodology

A.

B.

C.D.E.F.

OrganizationPersonnel qualification and training

A.B.

Documentation and record-keeping requirementsIII.Standard Operating ProceduresAnalytical MethodsRaw data (notebooks, print-outs)Document management (change control, retention)Part 11 (electronic records and signatures)

A.B.C.D.E.

ProtocolsTestsDocumentation

A.B.C.

QualificationCalibrationMaintenance

A.B.C.

Sample integrity requirementsIV.Sample collectionSample delivery, handling, dispositionRetain samples

A.B.C.

Stability (shelf-life) studiesV.Organization and managementStorage unitsAnalytical methodology

A.B.C.

1.2.3.4.5.

1.2.3.4.5.

Analytical methods verification and validationVI.

Management and control of laboratory instrumentsVII.

StandardsReagents, chemicals

A.B.

Management and control of laboratory suppliesVIII.

Out-of-specification resultsOut-of-norm resultsRoot cause analysisDocumentation

A.B.C.D.

Proper conduct of laboratory investigationsIX.

Consequences of laboratory non-complianceX.

Speaker is very knowledgeable. Glimpses "behind the curtain" in to the FDA are quite valuable in my opinion. ComplianceOnline has a broad catalog of professional advancement opportunities.

- Manager, Quality Control, Quanterix Corporation

The seminar was very informative for the cGMP course over multiple areas (drug, device and food). The open forum for questions and discussions was very valuable. Registration process for the seminar with ComplianceOnline was easy. Details of the course content were helpful. There was quick communication of required materials from ComplianceOnline after the registration.

- Quality Assurance Coordinator, Procter & Gamble

Speaker was informative. Contract laboratories topic was most valuable to me. Location was great. ComplianceOn-line staff was excellent in resolving the registration issues with hotel.

- Research & Development, Estée Lauder Companies

This seminar had a lot of excellent and useful information which will be beneficial for achieving compliance in our organization quality program. ComplianceOnline is very good at communicating and working with me.

- Quality & Safety Compliance Manager, Ala�a

Speaker was very informative, interesting and nice. All topics were important to me. Nice hotel and I was happy I had a copy of slides prior to make notes on.

- Research & Development, Estée Lauder Companies

Overall it was good seminar. ComplianceOnline was very good at email communication prior to the seminar.

- Quality Control Supervisor, International Flavors & Fragrances Inc.

The instructor was very knowledgeable and lab auditing topic was most valuable to me.

- Food Safety and Quality Coordinator, The Raymond-Hadley Corporation

It was good seminar. All topics were valuable to me. It was good review of cGMP.

- Quality Control Analyst, Fagron

Overall it was good seminar. Informal conversation with other attendees was beneficial.

- Manager Quality Engineering, Nuskin Products, Inc

The instructor was outstanding and very knowledgeable and shared great examples which really clarified the application of course material.

- Sr. VP Operations, Hologic Gen-Probe

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Great experience, very valuable. The instructor gave lot of great examples.

-- Sr. Director QC, Hologic Gen-Probe

Some of the anecdotes were useful, all were entertaining and informative in the general/public policy/historical sense. The ComplianceOnline responded promptly to questions.

- Quality Control Manager, ProZyme, Inc.

The instructor was experienced and knowledgeable.- QA/QC Manager, Nellson Nutraceutical

Sample SOPs were a good idea.

- QA Manager, Specialty Silicone Fabricators, Inc.

'Side notes' brought up by the presenter was interesting.

- QC Lab Manager, Usana Health Sciences

The presenter was extremely versatile/knowledgeable across the GxPs.

- GxP Vendor Compliance Management, AbbVie Laboratories

The presenter has a lot of experience in a variety of areas and shared stories and examples that helped in better understanding and were interesting.

- Lab Manager, PaxVax, Inc.

The presenter was very knowledgeable and the presentation was excellent.

- Associate Professor, University of Miami

The instructor was knowledgeable and experienced.- Quality Control Manager, Earthrise Nutritionals

Seminar provided broad overview of what the FDA is looking for during lab inspections.- Senior Scientist, Clorox Services Company

The instructor had so much experience and gave lot of examples that make the information easy to understand.

- Scientist I, ViaCyte, Inc

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.

- Director of Regulatory A�airs, Nickell Physician & Pharmacy Services

03QUALITY CONTROL LABORATORY COMPLIANCE - cGMPS AND GLPSOne and a Half-day In-person Seminar:

TESTIMONIALS

QUALITY CONTROL LABORATORY COMPLIANCE - cGMPS AND GLPSOne and a Half-day In-person Seminar:

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QUALITY CONTROL LABORATORY COMPLIANCE - cGMPS AND GLPS

Cancellations and Substitutions

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over. In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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